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|Item 8.01|| |
On September 29, 2020, Catalyst issued a press release reporting that the District Judge considering the Company’s lawsuit against the FDA has adopted the Report and Recommendation of the Magistrate Judge, granted the FDA’s and Jacobus’ motions for summary judgement, and dismissed Catalyst’s case. Catalyst is currently reviewing the District Judge’s decision, which it believes to be erroneous, and intends to appeal the result to the Eleventh Circuit Court of Appeals.
A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release issued by the Company on September 29, 2020.|
|104||Cover Page Interactive Data File (embedded within the inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Catalyst Pharmaceuticals, Inc.|
Vice President, Treasurer and CFO
Dated: September 29, 2020
Catalyst Pharmaceuticals Announces Ruling on Lawsuit against the FDA and Intent to Appeal
CORAL GABLES, Fla., September 29, 2020 (GLOBE NEWSWIRE) Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), today reported that the federal judge handling Catalysts case against the FDA has adopted the previously reported Report and Recommendation of the Magistrate Judge, granted summary judgment in favor of the FDA and Jacobus, and dismissed Catalysts case. Catalyst is currently reviewing the District Judges decision, which it believes to be erroneous, and intends to appeal the result to the Eleventh Circuit Court of Appeals.
In the order, the District Judge found that Catalysts interpretation of the Orphan Drug Act is not necessarily wrong, but it is not the only reasonable way to interpret the plain language of the statute. The District Judge found that the relevant statutory language was ambiguous and adopted FDAs interpretation rather than Catalysts. The District Judge also rejected Catalysts argument that the approved labeling for Ruzurgi® is false and misleading. As a result of the District Judges decision, Ruzurgi® remains approved for the treatment of pediatric LEMS patients in the United States.
Patrick J. McEnany, the Companys Chairman and CEO, stated: We are of course disappointed with Judge Blooms decision to accept the Magistrates Report and Recommendation in our lawsuit challenging the FDAs decision to approve Ruzurgi® for the treatment of pediatric patients with Lambert-Eaton Myasthenic Syndrome (LEMS). This decision in no way affects our Catalyst PathwaysTM patient services programs, market access for Firdapse® or our ongoing marketing efforts for Firdapse® to adult LEMS patients, which represent about 99% of the LEMS patient community.
Mr. McEnany continued: Judge Blooms decision also does not alter the fact that Jacobus Pharmaceuticals is not permitted to market Ruzurgi® to adult LEMS patients in the United States, and Catalyst intends to continue to aggressively take all steps necessary to protect Firdapse®s exclusivity under the Orphan Drug Act.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. Catalysts new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration (FDA), and Firdapse® is now commercially available in the United States. Further, Canadas national healthcare regulatory agency, Health Canada, recently approved the use of Firdapse® (amifampridine) for the treatment of adult patients with LEMS in Canada.
Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalysts actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst can successfully overturn the decision of the District Judge in the 11th Circuit Court of Appeals, (ii) whether Catalyst can continue to successfully market its product despite the lower price charged by Jacobus for its amifampridine drug, and (iii) those factors described in Catalysts Annual Report on Form 10-K for the fiscal year 2019 and Catalysts other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalysts filings with the SEC are available from the SEC, may be found on Catalysts website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Patrick J. McEnany
Chief Executive Officer